The following data is part of a premarket notification filed by Focus Diagnostics, Inc. with the FDA for Simplexa C. Difficile Universal Direct.
| Device ID | K113433 |
| 510k Number | K113433 |
| Device Name: | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT |
| Classification | C. Difficile Nucleic Acid Amplification Test Assay |
| Applicant | FOCUS DIAGNOSTICS, INC. 11331 Valley View Street Cypress, CA 90630 |
| Contact | Sharon Young |
| Correspondent | Sharon Young FOCUS DIAGNOSTICS, INC. 11331 Valley View Street Cypress, CA 90630 |
| Product Code | OMN |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2012-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816101025583 | K113433 | 000 |